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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05760911
Other study ID # kjb-wb-v1.1-20220507
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 15, 2023
Est. completion date September 30, 2024

Study information

Verified date March 2023
Source Shanghai Eye Disease Prevention and Treatment Center
Contact Haidong Zou, MD
Phone 02153555032
Email zouhaidong@sjtu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this multi-center, randomized, parallel-controlled clinical trial is to evaluate the effectiveness of outdoor activities monitoring and motivating by smartwatches to prevent myopia progression in children. The main question it aims to answer are: 1. To evaluate the two-year change of spherical equivalent progression. 2. To evaluate the change in axial length, the incidence of myopia, the time of outdoor activity, the choroid thickness, and blood flow through the two-year intervention. Participants will wear smartwatches and receive Mini Program outdoor activity reminders and motivations. The required outdoor activity time is 2 hours from Monday to Friday and more than 2 hours on weekends. The control group will only wear smartwatches for monitoring. Researchers will compare the control group and the intervention group to see if outdoor activities can protect myopia or not.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1200
Est. completion date September 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 4 Years to 9 Years
Eligibility Inclusion Criteria: 1. Gender is not limited; 2. Age: 4 ~ 9 years old; 3. Spherical equivalent: -0.5D < SE < 2.5D; 4. Be able to follow up for at least 2 years; 5. Be able to wear a smartwatch on a daily basis as required; 6. Parents or guardians sign an informed consent form; 7. Children over 6 years old need oral consent to participate. Exclusion Criteria: 1. Anisometropia > 1.50D; 2. Using other interventions for controlling myopia including atropine, rigid orthokeratology lenses, bifocal lenses or progressive lenses, red light, acupuncture, etc.; 3. Strabismus and/or amblyopia; 4. Previous history of eye surgery (including strabismus correction); 5. Ocular or systemic diseases that may be related to the development of myopia or myopia: such as Marfan syndrome, neonatal retinopathy, diabetes, etc.; 6. Other circumstances that the investigator judges inappropriate to participate in the trial.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Outdoor activities motivation with smartwatches
Wearing a smartwatch and receiving outdoor activity reminders and encouragement through a mini-program. The required outdoor time is at least 2 hours from Monday to Friday, and more than 2 hours on weekends.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Shanghai Eye Disease Prevention and Treatment Center Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Outcome

Type Measure Description Time frame Safety issue
Primary The change of spherical equivalent The mean change of spherical equivalent after cycloplegia was calculated during the study. Two years
Secondary The change of axial length The mean change of axial length by IOL Master was calculated during the study. Two years
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